FDA.reportPublic FDA data

BladeFlask EVO

Primary DI
29337363001838
Brand
BladeFlask EVO
Company
QLICKSMART PTY LTD
Model
QBVRMOPEC
Device description
The Qlicksmart BladeFlask EVO provides a simply safer way to remove used scalpel blades and can accommodate different types of scalpel handles and blades including large autopsy scalpels, thick and round handles, even hexagonal shaped versions - giving you greater freedom in using any scalpel you want. It is so simple to use with just one hand. Embrace safety with the new standard in scalpel blade removals and prevent the dangerous injuries commonly caused by removing blades with fingers, forceps or re-sheathing. BladeFlask EVO is simple to use with a quick “push, click, and pull” action to remove and contain used scalpel blades.
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MMKContainer, Sharps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMKContainer, SharpsGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213274000Qlicksmart BladeFlask UNIVERSALQlicksmart Pty , Ltd.2022-06-22MMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
29337363001838PackageGS124In Commercial Distribution
09337363001834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2933736300183829337363001838
09337363001834093373630018349337363001834

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel blade removerA non-powered device intended to be used to safely remove and contain scalpel blades from reusable scalpel handles after use. It is typically a sealed container into which a scalpel is pushed, whereby an internal mechanism detaches the blade from the handle; the blade is retained within the container. This device may be used in a clinical or laboratory setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
755003498
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09337363001834BladeFlask EVOQBVRMOPEC2023-06-23
09337363001841BladeFlask EVOQBVRGEN2023-06-23
29337363001845BladeFlask EVOQBVRGEN2023-06-23
09337363001209BladeFLASKQFRGEN2016-10-24
09337363001216BladeFLASKQFRGEN-012016-10-24
09337363001223BladeFLASKQFRUSAMOPEC2016-10-24
09337363001230BladeFLASKQFRUSAHAV2016-10-24
09337363001766BladeFlask EVO Blade RemoverQBVRGEN2021-01-27
09337363001780BladeFlask EVO Blade RemoverQBVRMOPEC2021-01-27
09337363001322Qlicksmart SnapIT Lite Large BurgundySN-02L2018-03-19
09337363001339Qlicksmart SnapIT Lite Regular GreySN-02RSN-02R2018-03-19
09337363001346Qlicksmart SnapIT Lite Regular PinkSN-02RSN-02Rpk2018-03-19
09337363001353Qlicksmart SnapIT Lite Regular BlueSN-02RSN-02Rb2018-03-19
09337363001360Qlicksmart SnapIT Lite Regular PurpleSN-02RSN-02Rpp2018-03-19
09337363001377Qlicksmart SnapIT Lite Blue with Boehringer Ingelheim LogoSN-02R-Bi2019-02-19
09337363001384Qlicksmart SnapIT Lite Grey with Cincinnati LogoSN-02R-Cc2019-02-19
09337363001513Qlicksmart SnapIT Trolley Extra LargeTE-01XL2019-03-22
09337363001520Qlicksmart SnapIT Regular BlueSN-01RSN-01Rb2018-03-19
09337363001537Qlicksmart SnapIT Regular PurpleSN-01RSN-01Rp2018-06-18
09337363001544Qlicksmart SnapIT Trolley RegularTE-01R2018-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00768627017275Norco Sharps ContainerNORTH COAST MEDICAL, INC.MMK2026-06-01
10192253005660NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005684NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005691NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005707NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005714NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005721NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005738NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005745NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005752NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10192253005769NOVAPLUSCardinal Health 200, LLCMMK2026-05-20
10197344118496MEDLINEMEDLINE INDUSTRIES, INC.MMK2024-11-28
16971292007088AUVONShenzhen Yuwen E-Commerce Co., Ltd.MMK2024-08-13
16971292007095AUVONShenzhen Yuwen E-Commerce Co., Ltd.MMK2024-08-13
10884521023192MonojectCardinal Health 200, LLCMMK2023-12-21
10884521023239MonojectCardinal Health 200, LLCMMK2023-12-21
20884521023113MonojectCardinal Health 200, LLCMMK2023-12-21
16947462492404GongdongZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.MMK2023-09-07
10884521141407SharpSafetyCardinal Health, Inc.MMK2023-08-23
09337363001834BladeFlask EVOQLICKSMART PTY LTDMMK2023-06-23
09337363001841BladeFlask EVOQLICKSMART PTY LTDMMK2023-06-23
10884521023062Sharps-A-GatorCardinal Health, Inc.MMK2023-02-06
10884521023338SharpSafetyCardinal Health, Inc.MMK2023-02-06
20884521076805Sharps-A-GatorCardinal Health, Inc.MMK2023-02-06
10080196282654MedlineMEDLINE INDUSTRIES, INC.MMK2022-11-30
10612479209340McKessonMCKESSON MEDICAL-SURGICAL INC.MMK2022-07-28
10073088161854BEMISBemis de México, S.A. de C.V.MMK2022-04-07
10888277171022MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18
10888277171107MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18
10888277171145MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMK2022-02-18